Clinical Effect and Safety Analysis of Liu Yingmin Long Round Needle in the Treatment of Cervical Spondylotic Radiotelegraphy and Its Effect on Pain and Functional Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Neck dysfunction index (NDI)
研究概览
简要总结
The goal of this clinical trial is to test in the clinical effect of long round needle in the treatment of cervical spondylotic radiculopathy, and analyze its safety and its influence on pain and functional recovery. The main question it aims to answer is whether long round needle therapy for patients with cervical spondylotic radiculopathy is effective and safe. Participants will be selected as the research objects. They will randomly divided into control group (n = 49) and observation group (n = 49). The control group was treated with filiform needle, and the observation group was treated with long round needle. Researchers will compare the two groups to see the differences on the therapeutic effect, safety, Neck dysfunction index (NDI), pain score (McGill pain questionnaire, MPQ), quality of life (Generic Quality of Life Inventory-74, GQOL-74), and levels of inflammatory factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) meet the efficacy criteria for disease certificate diagnosis of Traditional Chinese medicine[4]In the category of "Arthralgia Syndrome" and "Stiff neck", the main diseases: numbness and pain in the shoulder, neck and upper limbs, secondary diseases: unfavorable neck movement, hard, heavy head, thin coating, reddish tongue; (2) cervical X-ray shows hyperplasia of the vertebral body; (3) the patient or family members are informed and signed consent.
排除标准
- •(1) patients with severe periarthritis of shoulder and mixed cervical spondylosis; (2) spinal canal space-occupying lesions and cervical spine tumors; (3) serious immune system diseases and infectious diseases; (4) liver and kidney insufficiency; (5) cardiovascular and cerebrovascular diseases; (6) mental diseases or medical history; (6) patients with incomplete clinical data and poor compliance.
研究组 & 干预措施
Control group
The control group was treated with filiform needle.
干预措施: Filiform needle (Procedure)
Observation group
The observation group was treated with long round needle.
干预措施: Long round needle (Procedure)
结局指标
主要结局
Neck dysfunction index (NDI)
时间窗: Through study completion, an average of 1 year and 10 months
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
McGill pain questionnaire (MPQ) score
时间窗: Through study completion, an average of 1 year and 10 months
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
comprehensive assessment questionnaire (GQOL-74) scale
时间窗: Through study completion, an average of 1 year and 10 months
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
interleukin-8 (IL-8) level
时间窗: Through study completion, an average of 1 year and 10 months
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
interleukin-10 (IL-10) level
时间窗: Through study completion, an average of 1 year and 10 months
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
Neck dysfunction index (NDI)
时间窗: Before treament
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
McGill pain questionnaire (MPQ) score
时间窗: Before treament
Neck dysfunction index (NDI) was used, with 10 items, 0-5 points for each item, and the total score was 0-50 points. The score value was inversely related to the patient's cervical spine function.
comprehensive assessment questionnaire (GQOL-74) scale
时间窗: Before treament
Using the comprehensive assessment questionnaire (GQOL-74) scale, mainly including psychological function, social function, physical function and other items, the score value is positively correlated with the quality of life of patients.
interleukin-8 (IL-8) level
时间窗: Before treament
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
interleukin-10 (IL-10) level
时间窗: Before treament
5mL of fasting venous blood was extracted from the two groups before and after treatment, centrifuged at 3000 r/min and 8cm for 10 min.
次要结局
未报告次要终点
研究者
Zhanqing Xie
Deputy chief physician
The No. 2 Hospital of Baoding